title: Feasibility of outpatient fully integrated closed-loop control: first studies of wearable artificial pancreas.
abstract: OBJECTIVE
  To evaluate the feasibility of a wearable artificial pancreas system, the Diabetes Assistant (DiAs), which uses a smart phone as a closed-loop control platform.
  
  
  METHODS
  Twenty patients with type 1 diabetes were enrolled at the Universities of Padova, Montpellier, and Virginia and at Sansum Diabetes Research Institute. Each trial continued for 42 h. The United States studies were conducted entirely in outpatient setting (e.g., hotel or guest house); studies in Italy and France were hybrid hospital-hotel admissions. A continuous glucose monitoring/pump system (Dexcom Seven Plus/Omnipod) was placed on the subject and was connected to DiAs. The patient operated the system via the DiAs user interface in open-loop mode (first 14 h of study), switching to closed-loop for the remaining 28 h. Study personnel monitored remotely via 3G or WiFi connection to DiAs and were available on site for assistance.
  
  
  RESULTS
  The total duration of proper system communication functioning was 807.5 h (274 h in open-loop and 533.5 h in closed-loop), which represented 97.7% of the total possible time from admission to discharge. This exceeded the predetermined primary end point of 80% system functionality.
  
  
  CONCLUSIONS
  This study demonstrated that a contemporary smart phone is capable of running outpatient closed-loop control and introduced a prototype system (DiAs) for further investigation. Following this proof of concept, future steps should include equipping insulin pumps and sensors with wireless capabilities, as well as studies focusing on control efficacy and patient-oriented clinical outcomes.
authors.affiliation: Center for Diabetes Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia, Charlottesville, Virginia, USA. boris@virginia.edu
authors.forename: Boris P
authors.initials: BP
authors.lastname: Kovatchev
authors.forename: Eric
authors.initials: E
authors.lastname: Renard
authors.forename: Claudio
authors.initials: C
authors.lastname: Cobelli
authors.forename: Howard C
authors.initials: HC
authors.lastname: Zisser
authors.forename: Patrick
authors.initials: P
authors.lastname: Keith-Hynes
authors.forename: Stacey M
authors.initials: SM
authors.lastname: Anderson
authors.forename: Sue A
authors.initials: SA
authors.lastname: Brown
authors.forename: Daniel R
authors.initials: DR
authors.lastname: Chernavvsky
authors.forename: Marc D
authors.initials: MD
authors.lastname: Breton
authors.forename: Anne
authors.initials: A
authors.lastname: Farret
authors.forename: Marie-Josée
authors.initials: MJ
authors.lastname: Pelletier
authors.forename: Jérôme
authors.initials: J
authors.lastname: Place
authors.forename: Daniela
authors.initials: D
authors.lastname: Bruttomesso
authors.forename: Simone
authors.initials: S
authors.lastname: Del Favero
authors.forename: Roberto
authors.initials: R
authors.lastname: Visentin
authors.forename: Alessio
authors.initials: A
authors.lastname: Filippi
authors.forename: Rachele
authors.initials: R
authors.lastname: Scotton
authors.forename: Angelo
authors.initials: A
authors.lastname: Avogaro
authors.forename: Francis J
authors.initials: FJ
authors.lastname: Doyle
mesh_terms: D000328:Adult; D000368:Aged; D000465:Algorithms; D001786:Blood Glucose / Q000187:drug effects; D015190:Blood Glucose Self-Monitoring; D040421:Cell Phone; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy; D005260:Female; D005602:France; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D007328:Insulin / Q000008:administration & dosage / Q000627:therapeutic use; D007558:Italy; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D019397:Pancreas, Artificial; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin